Manage, Organize, Lead and Control Hikma Chemicals (APIs Site) functions “Production, Packaging & Labeling, Central operations, Technical support processes and activities” for all Steroidal and Non-steroidal products of 4 cGMP complying lines (Potent “Oncology” and Non-Oncology” lines) in alignment with the site, MENA, EU and US directions and regulations, in a safe manner, while providing the business units with products they require efficiently in a timely fashion at consistent, specified levels of quality and at a total cost capable of providing competitive leverage.

▷ Managing sterile, non-sterile and potent production processes within the APIs Plant and providing necessary guidance to support various production phases. ▷ Responsible for day-to-day production operations within the Sterile, non-sterile and potent manufacturing plants. ▷ Planning, scheduling, strategizing, and overseeing all sterile, non-sterile and potent production activities while continually building sales and maintaining profitability. ▷ Communicate effectively with the senior managements and the Production team, informing and updating them regularly to guarantee that production, sales, and production objectives are met.▷ Establishing production schedules while ensuring that the flow of production processes and production rate within the APIs Plant is in compliance with monthly production plan.▷ Ensuring that the safety, environmental and health regulations are being adopted and properly applied . ▷ Coordinating with the APIs Plant supply chain functions to check conformity of raw material inventory. ▷ Coordinating with the APIs Plant quality functions to ensure compliance of processes in various production phases with set quality standards.▷ Following up internal, external and corporate regulatory inspections while ensuring proper replies and effective corrective/preventive actions (CAPA) are considered on timely basis. ▷ Conducting regular maintenance investigations to check/ensure efficiency of production machines at the APIs sterile, non-sterile and potent Plants functions. ▷ Coordinating and suggesting regarding scale-ups preparations with R&D function.▷ Purchasing production equipment.▷ Supervises, motivates, and supports the staff daily.▷ Providing required training to subordinates. ▷ Developing solutions for potential hazardous situations in APIs Plant.▷ Initiate hiring when needed to cope with expanding workload or for replacement of substandard employees.

-Managing Hikma APIs RA activities and achievements; including annual targets, submission timelines, communicating with the FDA, EMEA and other regulatory agencies agents. -Manages all Hikma APIs RA activities; including KPIs, submissions timelines, advising other departments on regulatory requirements and regulatory developments.-Manages regulatory projects according to the annual regulatory strategy to achieve the best business outcomes. -Proactively manages regulatory requirements from all aspects of the business.